A PVC manual resuscitator is an emergency respiratory aid designed as a disposable bag-valve-mask (BVM) device, featuring a transparent PVC bag and mask. It delivers immediate manual ventilation for patients with respiratory arrest or inadequate breathing, intended for single-patient use to eliminate cross-infection risks. Widely used in emergency rooms, ambulances, operating rooms, and pre-hospital care, it serves as a critical life-saving tool when mechanical ventilation is unavailable or impractical.
Crafted from medical-grade PVC, the resuscitator's transparent bag allows visual monitoring of ventilation volume and rhythm, while the clear mask enables observation of the patient's lip color and facial expressions. The bag's flexible yet durable construction ensures consistent inflation and deflation with minimal effort, facilitating effective air delivery to the lungs. It is equipped with a one-way valve system that prevents exhaled gas from re-entering the bag, maintaining fresh air/oxygen supply for each breath. The mask features a soft, contoured edge that conforms to facial anatomy, creating a leak-proof seal to maximize ventilation efficiency. Compatible with oxygen sources (via an oxygen inlet port), it can deliver both room air and supplemental oxygen (up to 100% with oxygen attachment) to meet diverse emergency needs. Each unit undergoes strict quality testing, including leakage checks, valve functionality verification, and biocompatibility assessments, complying with ISO 13485, CE, and NMPA standards for safe emergency use.
Product Specification
|
Item |
Description |
|
Application |
Emergency ventilation for patients with respiratory arrest or inadequate breathing |
|
Type |
Disposable bag-valve-mask (BVM) device |
|
Material |
Medical-grade PVC |
|
Core Components |
PVC resuscitation bag, transparent mask, one-way valves, oxygen inlet port |
|
Ventilation Capacity |
Adult: 500-1000mL; Pediatric: 200-500mL; Infant: 100-200mL |
|
Oxygen Compatibility |
Accepts oxygen flow rates of 5-15 L/min |
|
Mask Sizes |
Adult, pediatric, infant |
|
Reusability |
Disposable |
|
Sterility |
EO-sterilized |
|
Shelf Life |
3 years |
Product Properties
- Emergency Ventilation: Delivers immediate manual breathing support for life-threatening respiratory situations.
- Transparent Design: Clear PVC bag and mask enable visual monitoring of ventilation effectiveness and patient status.
- Leak-Proof Seal: Soft, contoured mask edge conforms to facial anatomy, ensuring efficient air delivery.
- One-Way Valve System: Prevents gas re-entry, maintaining fresh air/oxygen supply and reducing contamination risks.
- Oxygen Compatible: Equipped with an oxygen inlet port to deliver supplemental oxygen for enhanced resuscitation.
Application
Emergency Rooms & ICUs:
Resuscitation of patients with respiratory arrest due to trauma, cardiac failure, or severe illness.
01
Ambulance & Pre-Hospital Care:
Ventilation support during patient transport to hospitals.
02
Operating Rooms:
Backup ventilation for patients during anesthesia induction or emergence.
03
Pediatric & Neonatal Care:
Size-adapted resuscitators for infants and children with respiratory distress.
04
Home & Long-Term Care:
Emergency support for patients with chronic respiratory conditions prone to acute exacerbations.
05
Physical Properties
|
Item |
Specification |
|
Operating Temperature |
5℃~40℃ |
|
Material Hardness |
Resuscitation bag: Shore A 40-45; Mask: Shore A 30-35 |
|
Product Weight |
Adult: 150-200g; Pediatric: 100-150g; Infant: 50-100g |
|
Mask Inner Diameter |
Adult: 8-10cm; Pediatric: 5-7cm; Infant: 3-5cm |
|
Valve Opening Pressure |
1-2 cmH₂O |
|
Oxygen Inlet Port Diameter |
6mm |
QA&QC
Certifications: Complies with ISO 13485, CE, and NMPA medical device standards. Each production batch undergoes leakage testing to ensure airtightness, valve functionality verification to confirm one-way flow, ventilation capacity checks to guarantee effective air delivery, and biocompatibility assessments (cytotoxicity, sensitization) for PVC materials. Unique batch number is assigned for full production and distribution traceability, and detailed Instruction for Use (IFU) and Material Safety Data Sheet (MSDS) are provided.
Packing,Storage,Handling and Transportation
Packing: Individual EO-sterilized paper-plastic composite packaging (includes resuscitation bag, mask, and valve assembly); bulk transport in sturdy corrugated cartons with anti-crush protection.
Storage: Store in a clean, dry, well-ventilated environment (temperature 5℃~40℃, relative humidity ≤80%). Avoid direct sunlight, high heat, or contact with sharp objects and corrosive substances. Keep packaging intact until use.
Handling: For single-patient use only-do not reuse or share to prevent cross-infection. Inspect the device for damage, cracks, or valve blockages before use. Ensure the mask forms a proper seal on the patient's face before initiating ventilation.
Transportation: Transport in accordance with medical device regulations. Protect from violent collision, rain, or moisture to preserve product sterility and structural integrity.
Reasons for choosing us
Zhejiang Mediunion Healthcare Group Co. Ltd. (a branch of Evergrand Healthcare Group, founded in 2014) is located in Ningbo City, Zhejiang Province - enjoying an excellent location and convenient transportation. Our business covers medical device manufacturing & sales, plus investments in nursing homes, dental clinics, specialist hospitals and medical care services. Our products are sold worldwide, and we've won global consumer recognition with high-quality goods and comprehensive after-sales service.
Diversified Product Portfolio
Our product range includes disposable medical consumables, medical equipment and non-woven products (e.g. dental supplies, respiratory care items). This diverse lineup caters to the needs of medical institutions, clinics and other clients.
Reliable Supply & Collaboration
We have rich industry experience and partner with over 600 factories. These partners are equipped with advanced production equipment and skilled frontline staff, enabling us to produce customized products/components as per specific requests.
Strict Quality Assurance
We prioritize innovation & quality, backed by the ISO 13485:2016 quality management system. Strict control runs through raw material procurement, mass production, process management and finished product release. Our professional services (production control, order follow-up, delivery) also set us apart.
Certificate
FAQ
Q:How long have you been producing this product?
A:We have been specializing in the production of this specific medical product for over 12 years. During this period, we have accumulated rich experience in process optimization, quality improvement, and regulatory compliance, and have served hundreds of customers worldwide with a proven track record of reliability.
Q:Do you support custom specifications or OEM/ODM?
A:Yes, we fully support custom specifications, OEM (Original Equipment Manufacturing), and ODM (Original Design Manufacturing) services. Our R&D and engineering teams can work with you to customize product dimensions, materials, functions, packaging, and labeling to meet your specific requirements. We also provide technical support throughout the customization process to ensure compliance with local regulations.
Q:What factors affect your pricing (volume, packaging, certifications)?
A:The key factors affecting our pricing include:
Order Volume: Larger order quantities qualify for higher volume discounts;
Customization Requirements: Specialized specifications, packaging, or labeling may incur additional costs;
Certifications: Products requiring additional regional certifications (beyond standard FDA/CE/ISO) may have slightly higher pricing due to certification costs;
Packaging Type: Premium packaging (e.g., sterile packaging, specialized tender packaging) or small-batch retail packaging may affect pricing;
Lead Time: Urgent orders requiring expedited production or shipping may involve additional fees.
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